Method validation in R&D and QC has evolved beyond statistical evaluation to become a core compliance-driven process. Today, it requires full integration into laboratory operations and the generation ...

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Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Company secures $5M in funding to accelerate its rapid testing platformUSP Validation achieved, reinforcing 20-hour testing methodFaster test results replace the standard 14-day USP sterility test SAN ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

Real world analysis of VTE incidence in lung cancer: A comprehensive assessment of the Khorana score and other clinical factors in predicting VTE incidence. This is an ASCO Meeting Abstract from the ...

Odor and safety risks in post-consumer plastics arise from diverse contaminants and degradation products, complicating ...